In order to harmonise the set of technical standards applied to the railways, Council Directive 96 /48/EC of 23 July on the interoperability of the trans-European high-speed rail system, has established essential requirements for the trans-European high-speed rail system, while at the same time determining the conditions to be met by the bodies responsible for assessing the conformity or suitability for use of the components of the interoperability and of the structural subsystems.

In order to incorporate the Community Directive into national law, it is necessary to collect the requirements laid down therein, distinguishing those relating to the so-called interoperability constituents and those which they have to do with the so-called structural subsystems. It is also intended to determine its scope and to regulate the procedures for the declaration and assessment of conformity, as well as the competent authorities in these matters.

Competition to incorporate into national law Council Directive 96 /48/EC of 23 July, in addition to the title of competition contained in the final provision of this Royal Decree, by the provision Amendment No 7 of Law 16/1987 of 30 July on the Management of Land Transports, which authorizes the Government to issue, on a proposal from the Ministry of Public Works, the provisions necessary for the implementation and development of this Law.

In its virtue, on the proposal of the Minister of Public Works, in agreement with the Council of State and after deliberation of the Council of Ministers at its meeting on June 23, 2000,

D I S P O N G O:

CHAPTER I

General rules

Article 1. Object.

1. The purpose of this Royal Decree is to lay down the conditions to be fulfilled for the interoperability of the Spanish part of the trans-European high-speed rail system, as described in Annex I.

2. These conditions relate to the project, construction, adaptation and operation of the infrastructure and rolling stock which are in the operation of the system which are put into service after the date of entry into force of this Regulation. Royal Decree.

3. For each subsystem, this Royal Decree refers to the provisions relating to the parameters, the interoperability constituents, the interfaces and the procedures, as well as the conditions for the overall coherence of the rail system High-speed trans-European networks required to achieve interoperability.

Article 2. Definitions.

For the purposes of this Royal Decree, it shall be understood as:

(a) Trans-European high-speed rail system: the set of railway infrastructure, including fixed lines and installations, of the trans-European transport network, built or upgraded to be (a) high speed travel, and the rolling stock designed to cover such infrastructure, as described in Annex I.

(b) Interoperability: the capacity of the trans-European high-speed rail system to enable the safe and uninterrupted movement of high-speed trains in compliance with specified yields.

This capacity shall be based on the set of regulatory, technical and operational conditions to be met to meet the essential requirements.

(c) Subsystems: the trans-European high-speed rail system shall be divided into structural or functional subsystems for which essential requirements are to be defined, as set out in Annex II.

(d) Interoperability components: any elementary component, group of components, subassembly or complete set of materials incorporated or intended to be incorporated into a subsystem, of which it is directly or indirectly dependent the interoperability of the trans-European high-speed rail system.

(e) Essential requirements: the set of conditions to be met by the trans-European high-speed rail system, the subsystems and the interoperability constituents, as described in Annex III.

(f) European specification: a common technical definition, European technical certification or national standard incorporating a European standard, as defined in Article 11 of Law 48/1998 of 30 December on procedures In the case of transport in the water, energy, transport and telecommunications sectors, Directives 93 /38/EEC and 92 /13/EEC are incorporated.

g) Technical specifications for interoperability (hereinafter referred to as "TSIs"): those of which each subsystem is subject, with a view to meeting the essential requirements, by which the relations are established Required reciprocal functional between

the subsystems of the trans-European high-speed rail system and the consistency of the system is guaranteed.

(h) Representative common body: the entity which brings together representatives of the infrastructure managers, railway undertakings and industry, which is responsible for drawing up the TSIs. Infrastructure managers shall be understood to mean what is indicated by Royal Decree 2111/1998 of 2 October 1998 governing the access to railway infrastructure in Article 3 thereof.

(i) Notified bodies: the entities responsible for assessing conformity or suitability for use of the interoperability constituents or for processing the "EC" verification procedure of the subsystems.

Article 3. Mandatory requirements for essential requirements.

1. The trans-European high-speed rail system, the subsystems and the interoperability constituents shall comply with the essential requirements for them.

2. The technical requirements of the contract documents which are necessary to comply with the European specifications or other rules in force shall not be contrary to the essential requirements.

Article 4. Derogations from the application of the TSIs.

1. The subsystems shall be in conformity with the TSIs, which shall be maintained on a permanent basis during use.

However, the Secretary of State for Infrastructure may agree that certain TSIs, including those relating to rolling stock, shall not be applied in the following cases and conditions:

(a) For a new line project or line conditioning project already in place to adapt it at high speed, which is in the advanced stage of development at the time of publication of these TSIs.

The European Commission will be notified in advance of the intention to introduce an exception, informing itself of the degree of project development and a dossier will be sent with the TSIs or parts of TSIs that are not intended to be applied, provisions to be put into practice in the implementation of the project in order to promote its interoperability in the future, and the technical, administrative or economic reasons for such an exception.

b) For an existing line conditioning project to adapt to high speed, when the gauge, width or wheelbase of the tracks of the line, have different values to those existing in the largest part of the European rail network and where that line does not constitute a direct connection with the high-speed network of another Member State which is part of the trans-European high-speed network.

The European Commission shall be notified in advance of the intention to introduce an exception by referring a file to the TSIs or parts of the TSI relating to the parameter or physical parameters referred to in the preceding paragraph. (a) to ensure that they do not apply, the provisions to be put into practice in the implementation of the project in order to promote their interoperability in the future, the transitional measures to ensure the compatibility of the operation and the reasons technical, administrative or economic reasons for such derogation.

(c) For an existing line conditioning project to adapt to high speed, when the application of these TSIs jeopardises the economic viability of the project.

The European Commission shall be notified in advance, for the purpose of the adoption of the relevant decision, of the intention to introduce an exception and a dossier shall be submitted with the TSIs or parts of the TSI that are not intended to be apply.

2. The TSIs shall not preclude the decisions of the competent bodies relating to the use of new or upgraded infrastructure for the movement of other trains.

3. The implementation of the TSIs should not create obstacles from the point of view of profitability to the maintenance of the consistency of the Spanish rail network.

The compliance of the TSIs should enable a high-speed rail system to maintain in an appropriate manner the consistency of the existing rail network.

Article 5. Motivation.

Any decision taken pursuant to this Royal Decree concerning the assessment of conformity or suitability for use of interoperability constituents, the verification of system components Trans-European high-speed rail, as well as the decisions taken pursuant to Articles 8.3, 9 and 14 shall be fully justified.

The person concerned shall be notified as soon as possible, indicating the remedies available to the legislation in force and the time limits for such remedies to be provided.

CHAPTER II

Interoperability components

Article 6. Competition.

The Secretary of State for Infrastructure shall take all appropriate measures to ensure that the interoperability constituents are:

(a) Only be placed on the market if they permit the interoperability of the trans-European high-speed rail system, in accordance with the essential requirements.

(b) They are used in the field for which they are intended and are properly installed and maintained.

These measures will not hinder the marketing of such components for other applications or their use on conventional rail lines.

Article 7. Marketing.

It shall not be possible to prohibit, restrict or impede the placing on the market of interoperability constituents for use in the high-speed rail system when such components comply with the provisions of this Royal Decree.

Article 8. Compliance with the essential requirements.

1. They shall be deemed to be in conformity with the essential requirements applicable to them, the interoperability constituents bearing the EC declaration of conformity or suitability for use, the elements of which are set out in Annex IV.

2. Compliance with an interoperability constituent of the essential requirements applicable to it shall be determined in relation to the relevant European specifications, if they exist.

3. Where it is considered that European specifications do not comply with the essential requirements, the Secretary of State for Infrastructure may withdraw those specifications from the publications in which they are registered or propose their amendment.

Article 9. Restrictions on the application of interoperability constituents.

1. If it is found that an interoperability constituent provided with the EC declaration of conformity or suitability for use, which is marketed and is used for the purpose for which it is intended, may endanger the compliance of the essential requirements, the Secretary of State for Infrastructure shall take all necessary measures to restrict its application, to prohibit its use or to withdraw it from the market. The European Commission shall be immediately informed of the measures taken to indicate the reasons for this decision, specifying in particular whether the non-compliance is derived from:

a) Non-compliance with the essential requirements.

b) incorrect application of the European specifications in case the application of those specifications is invoked.

c) An insufficiency of European specifications.

2. Where an interoperability constituent provided with the 'EC' declaration of conformity is not compliant, the Secretariat of State for Infrastructure shall order the opening of an information dossier to determine the causes for the purposes of the measures that are relevant are taken. The European Commission and the other Member States of the European Union shall be informed thereof.

Article 10. The EC declaration of conformity.

1. In order to issue the EC declaration of conformity or suitability for use of an interoperability constituent, the manufacturer, or his authorised representative established within the European Community, shall apply the provisions laid down by the TSIs which concern him.

2. Where the TSIs oblige, the assessment of conformity or suitability for use of an interoperability constituent shall be carried out by the notified body to which the manufacturer or his authorised representative established in the European Community, has requested such an assessment.

3. If any of the interoperability constituents are the subject of other Community Directives on other aspects, the "EC" declaration of conformity or suitability for use shall indicate, in such a case, that these interoperability constituents comply with the requirements of this Directive. also the requirements of those directives.

4. If the manufacturer and his authorised representative established in the European Community do not comply with the obligations referred to in paragraphs 1, 2 and 3, they shall be the responsibility of any person who places the interoperability constituent concerned on the market. The same obligations shall affect those who assemble the interoperability constituents or parts of the interoperability constituents of different origin or the manufacture for their own use, for the purposes of this Royal Decree.

5. Without prejudice to the provisions of the foregoing Article:

(a) Any finding that the "EC" declaration of conformity has been improperly issued shall mean that the manufacturer or his authorised representative established within the European Community is obliged to amend the interoperability constituent to do so as and to stop the infringement.

(b) Where non-compliance persists, the Secretary of State for Infrastructure shall take appropriate measures to restrict or prohibit the placing on the market of the interoperability constituent in question or to withdraw it from the market in accordance with the provisions of the previous article.

CHAPTER III

Structural character subsystems

Article 11. Put into service.

It is for the Secretariat of State of Infrastructures to authorize the putting into service of the structural subsystems of the trans-European high-speed rail system that are implemented in the territory of the Spain or operating the railway undertakings established in Spain.

To this end, the Secretariat of State of Infrastructure shall take the necessary measures to ensure that these subsystems are only allowed to enter into service if they are granted, manufactured and installed and/or exploited in such a way that the compliance with the essential requirements affecting them, when they are integrated into the trans-European high-speed rail system.

Article 12. EC declaration of verification.

1. They shall be regarded as interoperable and in accordance with the essential requirements affecting them, the structural subsystems constituting the trans-European high-speed rail system which are equipped with the EC declaration of verification.

2. The verification of interoperability, with respect to the essential requirements, of a structural subsystem constituting the trans-European high-speed rail system shall be determined by reference to the TSIs, if they exist.

3. If it is found that the TSIs do not comply fully with the essential requirements, the Committee provided for in Article 31 of Directive 96/48 shall be consulted.

The consultations will be carried out by the Secretariat of State for Infrastructure.

Article 13. EC declaration of verification procedure.

1. In order to issue the 'EC' declaration of verification, the contracting entity or its representative shall process the 'EC' verification procedure to the notified body which it has chosen for that purpose.

2. The function of the notified body responsible for the 'EC' verification of a subsystem shall start at the project stage and cover the entire construction period until the approval stage, before the subsystem is put into service.

3. The notified body shall be responsible for the establishment of the technical file which must accompany the EC declaration of verification. That technical file shall contain all the necessary documentation relating to the characteristics of the subsystem and, where appropriate, all elements proving the conformity of the interoperability constituents. It shall also contain all the elements relating to the conditions and limits of use and to the instructions for storage, continuous or periodic observation, regulation and maintenance.

Article 14. Supplementary verification.

1. Where it is established that a subsystem of a structural nature, provided with the "EC" declaration of verification accompanied by the technical file, does not fully comply with the provisions of this Royal Decree, and in particular the essential requirements, to request that additional verifications be carried out.

2. In this case, the Secretariat of State for Infrastructure shall immediately inform the Commission of the additional verifications requested, stating the reasons for them.

3. Without prejudice to the foregoing paragraphs, it shall not be possible to prohibit, restrict or impede for reasons which affect the provisions of this Royal Decree, the construction, putting into service and the operation of sub-systems of a nature structural components of the trans-European high-speed rail system where these meet the essential requirements.

CHAPTER IV

Notified Bodies

Article 15. Recognition of notified bodies.

1. The Secretariat of State for Infrastructure shall, where appropriate, notify the Commission and the other Member States of the European Union of the bodies responsible for carrying out the procedure for the assessment of conformity or suitability for use. provided for in Article 10 and the verification procedure laid down in Article 13, indicating the area of competence of each.

2. The criteria set out in Annex VII for the assessment of the bodies to be notified shall apply. Bodies which satisfy the assessment criteria laid down in the relevant European standards shall be presumed to comply with those criteria. The Secretariat of State for Infrastructure, in order to verify that such bodies meet the requirements, may require them to provide the necessary documentation.

3. The Secretariat of State for Infrastructure shall withdraw the authorisation granted to bodies which cease to comply with the criteria set out in Annex VII. It shall immediately inform the Commission and the other Member States thereof.

4. If the Secretariat of State for Infrastructure considers that a body notified by another Member State does not meet the relevant criteria, the matter shall be submitted to the Committee provided for in Article 21 of Directive 96/48 on the interoperability of the trans-European high-speed rail system.

Single repeal provision. Regulatory repeal.

As many provisions of equal or lower rank are repealed, they oppose the provisions of this Royal Decree.

Final disposition first. Competition from the State.

This Royal Decree is issued pursuant to the provisions of Article 149.1.21.a of the Constitution, which attributes to the State the competence in the field of railways and land transports that pass through the territory of more than an Autonomous Community and the general communications system.

Final disposition second. Regulatory development.

The Minister of Public Works is authorised to lay down the rules necessary for the development and implementation of this Royal Decree and to amend its annexes as necessary as a result of the provisions of the legislation. Community.

Final disposition third. Entry into force.

This Royal Decree will enter into force on the day following its publication in the "Official State Gazette".

Given in Madrid on June 23, 2000.

JOHN CARLOS R.

The Minister of Development, FRANCISSCOALVAREZ-CASCOSFERNCÓGS

ANNEX I

Trans-European high-speed rail system

1. Infrastructure

(a) The infrastructure of the trans-European high-speed rail system shall be those of the lines of the trans-European transport network specified in the framework of the guidelines referred to in Article 155 of the Treaty Establishing the European Community:

1.o That they are specially built to be traveled at high speed.

2.o That they are specially conditioned to be traveled at high speed.

They may include malside and link lines, in particular new or upgraded line connections with the city centre stations, and at which speeds must be taken into account. local conditions.

b) High-speed lines will include:

1.o The specially constructed high-speed lines equipped for speeds generally equal to or greater than 250 km/h.

2.o The specially upgraded high-speed lines equipped for speeds of the order of 200 km/h.

3.o The lines specially upgraded for high speed, of a specific character due to topographical difficulties, of relief or of urban environment, whose speed must be adjusted on a case by case basis.

2. Rolling stock

High-speed trains of advanced technology must be designed to ensure safe and uninterrupted movement:

(a) At a speed of at least 250 km/h on the lines specially constructed for high speed, at the same time, in the appropriate circumstances, reach speeds exceeding 300 km/h.

b) At a speed of the order of 200 km/h on the existing lines specially conditioned.

c) At the highest possible speed on the other lines.

3. Consistency of infrastructure and rolling stock

High-speed train services assume an excellent degree of consistency between the characteristics of the infrastructure and the characteristics of the material

rolling. The level of benefits, the security, the quality of services and their cost depend on such consistency.

ANNEX II

Subsystems

1. For the purposes of this Royal Decree, the system establishing the trans-European high-speed rail system may be divided into subsystems, corresponding to:

1. Well to areas of structural nature:

a) Infrastructure.

b) Energy.

c) Control and Command and Signalling.

d) Rolling stock.

2. Bien to scopes of functional nature:

a) Maintenance.

b) Environment.

c) Exploitation.

d) Users.

2. For each of the subsystems, the list of aspects relating to interoperability shall be set out in the mandates entrusted to the joint representative body for the preparation of the draft TSIs.

3. The following elements shall be considered in particular fundamental parameters for interoperability:

a) Minimum infrastructure gauge.

b) Minimum curve Radios.

c) Path width.

d) Maximum efforts on the track.

e) Minimum length of the platforms.

f) Height of the platforms.

g) Power voltage.

h) Geometry of the catenary.

i) Characteristics of ERTMS (1).

j) Load by axis.

k) Maximum length of trains.

l) A gauge of the rolling stock.

m) Minimum braking characteristics.

n) Electrical characteristics of the rolling stock.

n) Mechanical characteristics of the rolling stock.

o) Characteristics of the operation linked to the safety of the trains.

p) Limit characteristics related to external noise.

q) Limit characteristics related to external vibrations.

r) Limit characteristics related to external electromagnetic disturbances.

s) Limit characteristics related to indoor noise.

t) Limit characteristics related to air conditioning.

u) Characteristics related to the transport of disabled persons.

The fundamental parameters that are necessary for the fulfilment of the essential requirements will be determined by each TSI.

(1) European Rail Traffic Management System.

ANNEX III

Essential Requirements

1. General requirements

1. Security.

(a) The design, construction or manufacture, maintenance and monitoring of safety critical components and, in particular, of the elements involved in the movement of trains, must ensure the security at the level corresponding to the objectives set for the network, even in defined degraded situations.

b) The parameters of the wheel-rail contact must meet the criteria necessary to ensure a fully safe circulation at the maximum authorised speed.

c) The components used must resist the normal or exceptional efforts specified during their service period. By applying appropriate means, the impact of their accidental failures on safety should be limited.

(d) In the design of fixed installations and rolling stock, as well as in the choice of materials, account must be taken of the objective of limiting the production, propagation and effects of fire and smoke in the event of fire.

e) Devices intended to be handled by users must be designed in such a way that they do not endanger the safety of users in the event of a use which, although foreseeable, does not comply with the indications of the cartels information.

2. º Reliability and availability.

The monitoring and maintenance of fixed and mobile elements involved in the movement of trains should be organised, carried out and quantified so that their role is continued in the planned conditions.

3. Health.

(a) Materials which, by way of use, may endanger the health of persons who have access to them must not be used on trains or on railway infrastructure.

(b) In the choice, putting into service and use of these materials, the objective of limiting the emission of harmful and dangerous fumes or gases, especially in the event of fire, must be taken into account.

4. Environmental protection.

(a) In the design of the trans-European high-speed rail system, the impact of its implementation and exploitation on the environment should be assessed and taken into account in accordance with Community provisions. in force.

(b) Materials used in trains and infrastructure should avoid the emission of fumes or gases that are harmful and dangerous to the environment, especially in the event of fire.

(c) The rolling stock and power supply systems must be designed and constructed to be electromagnetic compatible with the facilities, equipment and public or private networks with which the may interfere.

5. Technical Compatibility.

The technical characteristics of the infrastructures and fixed installations must be compatible between

yes and with those of the trains that will run through the trans-European high-speed rail system.

If, in some parts of the network, it is difficult to adjust to these characteristics, temporary solutions could be applied to ensure future compatibility.

2. Specific requirements for each subsystem

1. Infrastructures.

Security.

Appropriate measures will be taken to prevent undesirable access or intrusion into the facilities of the lines through which high-speed circuits are to be circulated.

Measures should also be taken to limit the danger to persons, especially at the time of the passage through the stations of trains running at high speed.

The infrastructure to which the public has access must be designed and constructed in such a way as to limit the risks to the safety of persons (stability, fire, access, evacuation, anden, etc.).

The appropriate arrangements should be made to take into account the special safety conditions in long-distance tunnels.

2. Energy.

a) Security.

The operation of power supply facilities should not endanger the safety of high-speed trains or people (users, railway staff, people living in the environment and others).

b) Environmental protection.

The operation of power supply facilities should not affect the environment beyond the specified limits.

c) Technical compatibility.

The power supply systems used in the trans-European high-speed rail system should enable trains to perform the performance in line with their specifications and to be compatible with the Catch devices installed on trains.

3. Control and Command and Signalling.

a) Security.

The control and command and signalling facilities and operations used for the trans-European high-speed rail system shall permit a movement of the trains which present the level of safety corresponding to the objectives set for the network.

b) Technical compatibility.

All new high-speed infrastructure and all new high-speed rolling stock built or developed after the adoption of compatible control and control systems and signalling systems must be adapted to the use of such systems.

Control and control equipment and signalling equipment installed in the train station shall allow a normal operation, under the specified conditions, throughout the trans-European high rail system. speed.

4. Rolling stock.

a) Security.

The structures of the rolling stock and the connections between vehicles must be designed to protect the passenger and driving areas in the event of a collision or derailment.

Electrical equipment should not endanger the safety of operation of control and command and signalling facilities.

The braking techniques and the efforts exerted must be compatible with the design of the tracks, structures and signalling systems.

Measures should be taken on access to components under electrical stress so that the safety of people is not compromised.

There should be devices that, in the event of danger, allow passengers to point to the driver and train staff to contact the driver.

Access doors must be equipped with a system of closure and opening that ensures the safety of the passengers.

Emergency exits must exist and must be marked.

Appropriate arrangements should be made to take into account the special safety conditions in long-distance tunnels.

It will be mandatory on board trains a system of aid lighting with sufficient intensity and autonomy.

Trains should carry a sound system that allows staff on board the train and ground control personnel to be able to direct messages to passengers.

b) Reliability and availability.

The design of the main equipment, bearing, traction and braking, as well as control and control, must allow, in a defined degraded situation, the continuation of the journey without harmful consequences for the equipment which continue to operate.

c) Technical compatibility.

Electrical equipment must be compatible with the operation of control and command and signalling facilities.

The characteristics of the current collection devices must allow the movement of the trains with the power supply systems of the trans-European high-speed rail system.

The characteristics of the rolling stock must allow it to circulate on all lines in which it is intended to be operated.

5. Maintenance.

a) Health.

The technical facilities and procedures used in maintenance centres should not pose a threat to people's health.

b) Environmental protection.

The technical facilities and procedures used in maintenance centres should not exceed the levels of harmfulness that are acceptable to the environment.

c) Technical compatibility.

The maintenance facilities in which high-speed trains are treated must allow the safety, hygiene and comfort operations to be carried out on all trains for which they were designed.

6. Environment.

a) Health.

The operation of the trans-European high-speed rail system must be in line with the regulatory standards for noise pollution.

b) Environmental protection.

The operation of the trans-European high-speed rail system must not generate ground vibrations that are inadmissible for the activities and the environment close to the infrastructure and in the normal state of maintenance.

7. Operation.

a) Security.

The consistency of the operating rules of the networks together with the qualification of drivers and train staff should ensure an international exploitation in safety conditions.

The operations and periodicity of the maintenance, training and qualification of the staff doing this work and the quality assurance system established in the maintenance centres to which the operators belong They must ensure a high level of safety.

b) Reliability and availability.

The operations and periodicity of the maintenance, training and qualification of the staff doing this work and the quality assurance system created by those responsible for the operation in the maintenance centres must ensure a high level of system reliability and availability.

c) Technical compatibility.

The consistency of the operating rules of the networks, together with the qualifications of the drivers, train staff and the management of the traffic management, must ensure the effectiveness of the operation in all the Trans-European high-speed rail system.

ANNEX IV

Interoperability components

EC DECLARATION OF CONFORMITY AND SUITABILITY FOR USE

1. Interoperability constituents

The EC declaration shall apply to interoperability constituents relating to the interoperability of the trans-European high-speed rail system referred to in Article 1.3. These interoperability constituents can be:

a) Common components.

Non-proprietary components of the rail system that can be used for other applications without modification.

b) Common components with specific characteristics.

The components that, as such, are not specific to the rail system, but which must offer certain specific benefits when they are to be used in it.

c) Specific components.

The components of the railway applications.

2. Scope of application

The "CE" declaration refers to:

(a) Either to the assessment, by one or more notified bodies, of the intrinsic conformity of an interoperability constituent, considered in isolation, with the technical specifications to be adjusted.

(b) Õ the assessment/assessment by one or more notified bodies of the suitability for use of an interoperability constituent, considered in its railway environment, in particular when interfaces are involved, with the technical specifications, in particular functional ones, which must be verified.

For the assessment procedures carried out by the notified bodies at the design and production stages, the modules defined in Decision 93 /465/EC shall be used, in accordance with the procedures laid down in the the TSIs.

3. Content of the 'EC' declaration

The "EC" declaration of conformity or suitability for use and the accompanying documents shall be duly dated and signed.

This statement must be written in the same language as the instructions for use, and shall contain the following elements:

a) Reference to Directive 96/48 on the interoperability of the trans-European high-speed rail system.

(b) Name, surname and address of the manufacturer or his authorised representative established in the European Community.

c) Description of the interoperability constituent (brand, type, etc.).

(d) Indication of the procedure followed for declaring conformity or suitability for use (Article 10).

e) All relevant descriptions to which the interoperability constituent is adjusted and in particular the conditions of use.

(f) Name and address of the notified body or bodies involved in the procedure followed for the conformity or suitability for use and the date of the certificate of inspection, in which, where appropriate, the period and the conditions of validity of such a certificate, where appropriate, the reference of the European specifications.

(g) Identification of the signatory to the manufacturer or his authorised representative established in the European Community.

ANNEX V

Subsystems

EC Statement of Verification

The EC declaration of verification and accompanying documents shall be duly dated and signed:

This declaration must be in the same language as the technical file, and shall contain the following elements:

a) Reference to Directive 96/48 on the interoperability of the trans-European high-speed rail system.

(b) Name and address of the contracting entity or its representative established in the European Community (the social reason and full address shall be indicated).

c) Brief description of the subsystem.

(d) Name and address of the notified body which has carried out the 'EC' verification referred to in Article 13.

e) References of the documents contained in the technical file.

(f) All relevant, provisional or definitive provisions, which the subsystem must comply with, and in particular, where appropriate, the operating restrictions or conditions, if provisional: the period of validity of the "CE" declaration.

g) Identification of the signatory.

ANNEX VI

Subsystems

CE Verification

1. 'EC' verification is the procedure whereby a notified body checks and certifies, at the request of the contracting entity, that a subsystem is:

a) In accordance with the provisions of this Royal Decree and the Community rules.

b) In accordance with the other regulatory provisions implementing the Treaty, and may be put into service.

2. Subsystem verification covers the following stages:

a) Global design.

b) Manufacturing of the subsystem, including the execution of civil engineering works, assembly of components and the regulation of the assembly.

c) Trials of the finished subsystem.

3. The notified body responsible for the 'EC' verification shall issue the certificate of conformity for the contracting entity which, in turn, shall issue the 'EC' declaration of verification to the State Secretariat for Infrastructure.

4. The technical file attached to the verification declaration shall be structured as follows:

(a) For the infrastructure: drawings of the works, records of approval of excavations and armor, reports of tests and control of concrete.

b) For other subsystems: general and detailed plans in accordance with the implementation, electrical and hydraulic schemes, control circuit schemes, description of computer systems and automatisms, operation and maintenance, etc.

c) List of interoperability constituents incorporated into the subsystem.

(d) Copies of the "EC" declarations of conformity or suitability for use for which the said components must be provided, in accordance with the provisions of Article 10 of this Royal Decree, accompanied, where appropriate, by the the relevant calculations and a copy of the test reports and inspections carried out by notified bodies on the basis of the common technical specifications.

(e) Certificate of the notified body responsible for the "EC" verification that the project is in accordance with the provisions of this Royal Decree, together with the corresponding booklets of calculation visas by that body and where, where appropriate, the reservations made during the execution of the works are recorded and have not been withdrawn, accompanied by the reports of visits and audits which have been carried out by the Commission, as indicated in the paragraphs 5.c) and 5.d).

5. Surveillance.

(a) The "EC" surveillance is intended to ensure that the obligations arising from the technical file have been fulfilled during the performance of the subsystem.

(b) The notified body responsible for verifying the construction or manufacture must be able, at all times, to enter the works, manufacturing workshops, storage areas and, where appropriate, pre-manufacturing, in the premises and, in general, wherever it deems necessary for the performance of its function. The contracting entity should refer to it or have it sent to it all relevant documents, in particular the implementing plans and the technical documentation of the subsystem.

(c) The notified body verifying the performance shall carry out periodic audits to ensure that the provisions of this Royal Decree are complied with, and at that time submit a report of such audit to the professionals responsible for the realization.

It may be required to be convened at certain stages of the work.

(d) Moreover, the notified body may visit without notice the works or the workshops of manufacture.

On the occasion of these visits, you will be able to carry out full or partial audits. It shall provide a report of the visit and, where appropriate, an audit report to the professionals responsible for the performance.

6. The complete file referred to in paragraph 4 shall be deposited, in support of the certificate of conformity issued by the notified body responsible for the verification of the subsystem under operating conditions, to the contracting entity or their representative. The file shall be attached to the 'EC' declaration of verification which the contracting entity shall forward to the Secretary of State for Infrastructure.

The contracting entity will keep a copy of the file for the entire lifetime of the subsystem. The file shall be sent to the other Member States of the European Union upon request.

7. All notified bodies shall publish on a regular basis the relevant information related to:

a) The "CE" verification requests received.

(b) The certificates of conformity issued.

c) Denied compliance certificates.

8. The files and correspondence relating to the 'EC' verification procedures shall be drawn up in the official language of the State in which the contracting entity or its representative is established.

ANNEX VII

Minimum criteria to be taken into account by the Secretariat of State for Infrastructure for the Notification of Bodies

1. The body, its director and the staff responsible for the checks may not, either directly or in the capacity of the heads of state, intervene in the design, manufacture, construction, marketing or maintenance of the interoperability constituents or subsystems or on their holding. This does not preclude the possibility of an exchange of technical information between the manufacturer or the manufacturer and the body.

2. The body must have the staff and possess the necessary means to carry out the technical and administrative tasks relating to the conduct of the verifications; it must also have access to the necessary equipment for the Exceptional verifications.

3. The personnel responsible for the inspection shall have:

a) Good technical and professional training.

b) satisfactory knowledge of the obligations relating to the checks carried out, and a sufficient practice in such controls.

(c) The aptitude required to draw up the certificates, the minutes and the reports in which the checks carried out shall be carried out.

4. The independence of the inspection staff shall be ensured. The remuneration of an agent shall not be based on the number of inspections carried out or on the results of such inspections.

5. The body must take out civil liability insurance.

6. The staff of the body shall be bound by the obligation of professional secrecy in all cases where they are known in the course of their duties (except in the case of the competent administrative authorities of the State in which they carry out their activities). This Royal Decree or any rules of national law implementing Directive 96/48 on the interoperability of the trans-European high-speed rail system.